Article reprinted from "The Gray Sheet" - March 1, 2010
A new collaboration between the National Institutes of Health and FDA will spur research into new tools and methodologies to evaluate the safety and efficacy of innovative medical products. Read more...
NIH, FDA Seeking Better Methods To Evaluate MedTech Innovations
Article reprinted from "The Gray Sheet" - March 1, 2010
A new collaboration between the National Institutes of Health and FDA will spur research into new tools and methodologies to evaluate the safety and efficacy of innovative medical products.
"Much more can be done to speed the progress from new scientific discoveries to treatments for patients," Health and Human Services Secretary Kathleen Sebelius said at a news conference Feb. 24 in Bethesda, Md.
The collaboration to "speed the process from microscope to marketplace," as Sebelius put it, will include the awarding of grants, the formation of a joint agency council, and solicitation of public input into needed research areas.
A key problem is that methods for evaluating new device and drug therapies have failed to keep pace with advances in biomedical research, FDA Commissioner Margaret Hamburg said. As a result, outmoded review methods employed by FDA can delay approval of innovative treatments.
Advances in regulatory science will be needed, for example, for FDA to properly evaluate an artificial pancreas for juvenile diabetes and personalized treatments for cancer, FDA materials stated.
Grants Will Go To Improving Regulatory Science
NIH and FDA will award $6.75 million in grants over fiscal years 2011-2013 to support the development of better methods or technologies for evaluating the safety, quality, effectiveness and manufacturing of breakthrough products throughout their total lifecycle, the agencies announced.
The agencies will also set up a joint NIH-FDA leadership council, co-chaired by Hamburg and NIH Director Francis Collins, to spearhead collaborative work on important health issues, and to ensure that regulatory considerations at FDA form an integral part of biomedical research planning at NIH.
The council will include six senior scientists from each of the agencies, to be identified soon. Collins noted that before the council sets its agenda, it will take input from the public at a forum this spring.
Sebelius said NIH researchers need to begin sharing information about promising new medical technologies with FDA scientists "to help [regulators] develop, early on, the standards for safety and effectiveness."
"We feel this very type of relationship needs to be nurtured," Collins agreed.
Artificial Pancreas May Benefit
An FDA fact sheet distributed at the Feb. 24 press conference stated that better regulatory science tools are needed to speed the development of an "artificial pancreas" that would continuously monitor a patient's blood sugar and automatically deliver the right amount of insulin.
"But for patients to benefit, we must develop a scientifically solid path for testing to make sure the devices control blood sugar levels without placing patients at risk," FDA said.
Development of such a system has long been targeted by FDA's Critical Path program (The Gray Sheet' Feb. 25, 2008). "Critical Path was a great idea that never got all of the funding and traction it really needed," Hamburg told "The Gray Sheet."
"We're hoping through this effort we will revitalize the vision of Critical Path, but extend it and broaden it."
Industry, Not NIH, The Real Innovator, AdvaMed Says
While device industry trade association AdvaMed supports the NIH-FDA collaboration and associated grants funding, the group was quick to point out that the vast majority of medtech innovations come from private industry, not NIH.
"Whatever NIH spends in terms of R&D pales compared to what private enterprise spends on R&D," Michael Mussallem, AdvaMed chairman and CEO of Edwards Lifesciences said at a Feb. 24 AdvaMed policy briefing in Washington, D.C.
"So if we really want innovation ... what we really need to do is to stimulate that private investment and not think that the federal government has to shoulder the burden of innovation," Mussallem said.
AdvaMed CEO Steve Ubl said he is "concerned that a lot of policy makers believe if they 'plus up' the NIH, that they've checked the box on innovation, and the truth is a lot more complicated."
- Sue Darcey
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